MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 59T EZ GLIDE W/POWERTRAXX

Model Number 0731380

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  No Answer Provided  

Manufacturer Narrative

The device will be evaluated by a representatvie in (b)(6) and the results will be forwarded to manufacturer for review.

Event Description

It was reported from an international representative that an incident occurred in (b)(6) during which students at an academy were operating the stair chair and a student allegedly became pinned to wall while attempting to maneuver the chair in a confined area.There has been an allegation the student may have received injury to their rib; however, no verification of this allegation has been provided from the complainant, to date, and it is unknown if medical intervention was required as a result of the alleged incident.An investigation has been initiated to gather more details on the alleged incident and injury as well as an evaluation of the device being used.The serial number of the device has not been provided to date.

Manufacturer Narrative

The device will be evaluated by a representative in (b)(6) and the results will be forwarded to manufacturer for review.As of 8/18/2016 there has been no information returned to the manufacturer or complainant regarding the alleged incident or the alleged injury.The initial report stated it was unclear whether the users operated the paddle incorrectly (speed or direction) or whether the paddle pressed up against them and it activated in the confined space.A review of complaints in the last 2 years indicate only 2 similar complaints on the chair paddles, neither of which involved reported injuries, and were attributed to the need for lubrication or suspected damage to the controller itself.The serial number of the chair has still not been provided to the manufacturer.If further information is received as a means to confirm the alleged complaint a second follow up report will be submitted.

Event Description

It was reported from an international representative that an incident occurred in (b)(6) during which students at an academy were operating the stair chair and a student allegedly became pinned to wall while attempting to maneuver the chair in a confined area.There has been an allegation the student may have received injury to their rib; however, no verification of this allegation has been provided from the complainant, to date, and it is unknown if medical intervention was required as a result of the alleged incident.An investigation has been initiated to gather more details on the alleged incident and injury as well as an evaluation of the device being used.The serial number of the device has not been provided to date.

• Brand Name: 59T EZ GLIDE W/POWERTRAXX
• Type of Device: 59T EZ GLIDE W/POWERTRAXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 5708710
• MDR Text Key: 46881321
• Report Number: 1523574-2016-00016
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 0731380
• Device Catalogue Number: PT5910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other